Barbed suture having increased holding strength

Abstract

A wound closure device having a filamentary element having a proximal end and a distal end, and a stop element coupled thereto and having a leading edge area defined by thickness and a width and having a total surface area. The leading edge area is substantially perpendicular to a longitudinal axis of the filamentary element. The device may have a ratio of the leading edge area to the total surface area that is less than 10%, a ratio of the length to the maximum thickness of the stop element that is at least 4, or a ratio of the length to the width of the stop element is at least 1 for any given thickness.

What is claimed is: 
     
       1. A wound closure device configured to approximate opposing tissue surfaces without knot tying, the wound closure device comprising:
 a filamentary element extending along a longitudinal axis between a proximal end and a distal end, said filamentary element having a plurality of barbs extending outwardly therefrom, said plurality of barbs configured to allow movement through tissue in a first direction toward the proximal end of the filamentary element and resist movement in a second opposite direction toward the distal end of the filamentary element; and 
 a stop element connected to the distal end of the filamentary element, the stop element having a length extending along a direction of the longitudinal axis and a width extending in a perpendicular direction to the longitudinal axis, the stop element having a top edge and bottom edge defined along the length in the direction of the longitudinal axis, the top and bottom edges being generally parallel to each other along the length, the stop element further comprising a leading edge and a back edge defined along the width in the perpendicular direction to the longitudinal axis, the leading and back edges being generally parallel to each other along the width, the leading edge having a maximum thickness, and the stop element having a ratio of the length to the maximum thickness of the stop element greater than 4; 
 wherein the length of the stop element is greater than the width of the stop element, and wherein the width of the stop element is greater than the maximum thickness of the stop element. 
 
     
     
       2. The wound closure device according to  claim 1 , wherein the stop element comprises a leading edge area, the leading edge area facing substantially perpendicular to a longitudinal axis of the filamentary element, and a total surface area, wherein the ratio of the leading edge area to the total surface area is less than 10%. 
     
     
       3. The wound closure device according to  claim 1 , wherein the width of the stop element is greater than 70 mils. 
     
     
       4. The wound closure device according to  claim 3 , wherein the length of the stop element is greater than 70 mils. 
     
     
       5. The wound closure device according to  claim 1 , wherein the maximum thickness of said stop element is between 6 and 25 mils. 
     
     
       6. The wound closure device according to  claim 5 , wherein the stop element further comprises a minimum thickness, and wherein the minimum thickness of the stop element is between 4 and 12 mils. 
     
     
       7. The wound closure device according to  claim 1 , wherein the plurality of barbs extend outwardly from said filamentary element by approximately 6-25 mils. 
     
     
       8. The wound closure device according to  claim 1 , wherein the device is comprised of a polymeric, metallic or ceramic material that is absorbable or non-absorbable. 
     
     
       9. The wound closure device according to  claim 8 , wherein the device is comprised of a polymer material selected from the group consisting of absorbable and non-absorbable homopolymers, random copolymers, block copolymers or blends made from polydioxanone, polyglactin, polyglycolic acid, copolymers of glycolide, lactide, and/or caprolactone, polyoxaesters, poliglecaprone, polypropylene, polyethylene, polyvinylidene fluoride (PVDF), hexafluoropropylene, copolymers of vinylidene fluoride and hexafluoropropylene, polyesters, polyethylene terephthalate, polybutylene terephthalate, glycol-modified polyethylene terephthalate, polytetrafluoroethylene, fluoropolymers, thermoplastic elastomers, ionomers, copolymers of ethylene and methacrylic acid, polyamides, polytetramethylene oxide, polystyrene, polybutadiene, polybutylene, including combinations and/or copolymers of absorbable and non-absorbable materials. 
     
     
       10. The wound closure device according to  claim 1 , wherein the filamentary element and stop element are comprised of a same polymeric material. 
     
     
       11. The wound closure device according to  claim 1 , wherein the maximum thickness of the stop element is approximately 8-25 mils, the width of the stop element is approximately 70-120 mils, and the length of the stop element is approximately 39-200 mils. 
     
     
       12. The wound closure device according to  claim 1 , wherein the leading edge of the stop element extends between first and second outer edges of the stop element, wherein the leading edge of the stop element has a varying thickness between the first and second outer edges, and wherein the maximum thickness of the leading edge is located at the first and second outer edges and a center of the stop element and a minimum thickness of the leading edge is located at points between the first and second outer edges and the center of the stop element. 
     
     
       13. The wound closure device according to  claim 1 , wherein the ratio of the length of the stop element to the width of the stop element is greater than 1.5:1. 
     
     
       14. The wound closure device according to  claim 13 , wherein the ratio of the length of the stop element to the width of the stop element is greater than 2:1. 
     
     
       15. The wound closure device according to  claim 1 , wherein the ratio of the width of the stop element to the maximum thickness of the stop element is greater than 2:1. 
     
     
       16. The wound closure device according to  claim 15 , wherein the ratio of the width of the stop element to the maximum thickness of the stop element is greater than 4:1. 
     
     
       17. The wound closure device according to  claim 1 , further comprising a needle secured to the proximal end of the filamentary element. 
     
     
       18. A wound closure device configured to approximate opposing tissue surfaces without knot tying, the wound closure device comprising:
 a filamentary element extending along a longitudinal axis between a proximal end and a distal end, said filamentary element having a plurality of barbs extending outwardly therefrom, said plurality of barbs configured to allow movement through tissue in a first direction toward the proximal end of the filamentary element and resist movement in a second opposite direction toward the distal end of the filamentary element; and 
 a stop element connected to the distal end of the filament element, the stop element having a length extending along a direction of the longitudinal axis and a width extending in a perpendicular direction to the longitudinal axis, the stop element having a top edge and bottom edge defined along the length in the direction of the longitudinal axis, the top and bottom edges being generally parallel to each other along the length, the stop element further comprising a leading edge and a back edge defined along the width in the perpendicular direction to the longitudinal axis, the leading and back edges being generally parallel to each other along the width, the leading edge having a maximum thickness, and the stop element having a ratio of the length to the maximum thickness of the stop element greater than 4; 
 wherein the leading edge of the stop element extends between first and second outer edges of the stop element, wherein the leading edge of the stop element has a varying thickness between the first and second outer edges, and wherein the maximum thickness of the leading edge is located at the first and second outer edges and a center of the stop element and a minimum thickness of the leading edge is located at points between the first and second outer edges and the center of the stop element.